RxBlue 2009 PA Criteria
ACTIQ/FENTORA
ACTIQ®
FENTANYL CITRATE
FENTORA®
ALPHA-1 PROTEINASE INHIBITORS
ARALAST®
PROLASTIN®
ZEMAIRA®
AMEVIVE
AMEVIVE®
ANABOLIC STEROIDS
ANADROL-50®
OXANDRIN®
OXANDROLONE
ARANESP
ARANESP®
ARCALYST
ARCALYST®
AVONEX
AVONEX ADMINISTRATION PACK®
AVONEX®
B vs D - Part B versus Part D Coverage PA
ANZEMET®
AZASAN®
AZATHIOPRINE
CARIMUNE NF NANOFILTERED®
CELLCEPT®
CESAMET®
CYCLOPHOSPHAMIDE
CYCLOSPORINE
CYTOXAN®
DRONABINOL®
EMEND®
ENGERIX-B®
FLEBOGAMMA®
GAMASTAN S-D®
GAMMAGARD LIQUID®
GAMUNEX®
GENGRAF
GRANISETRON HCL
GRANISOL®
IMURAN®
IVEEGAM EN®
KYTRIL®
MARINOL®
METHOTREXATE
MYFORTIC®
NEORAL®
OCTAGAM®
ONDANSETRON HCL
ONDANSETRON ODT
PANGLOBULIN NF®
PANGLOBULIN®
PHENERGAN®
POLYGAM S-D®
PROGRAF®
PROMETHAZINE HCL
RAPAMUNE®
RECOMBIVAX HB®
SANDIMMUNE®
TREXALL®
ZOFRAN ODT®
ZOFRAN®
BETASERON
BETASERON®
BOTOX
BOTOX®
BYETTA
BYETTA®
CEREZYME
CEREZYME®
CIMZIA
CIMZIA®
COPAXONE
COPAXONE®
ENBREL
ENBREL®
EPOETIN/PROCRIT
EPOGEN®
PROCRIT®
FABRAZYME
FABRAZYME®
FORTEO
FORTEO®
GROWTH HORMONES
GENOTROPIN®
HUMATROPE®
NORDITROPIN NORDIFLEX®
NORDITROPIN®
NUTROPIN AQ®
NUTROPIN®
OMNITROPE®
SAIZEN®
SEROSTIM®
TEV-TROPIN®
ZORBTIVE®
HUMIRA
HUMIRA®
INCRELEX
INCRELEX®
KINERET
KINERET®
LAMISIL
LAMISIL®
TERBINAFINE HCL
LEUPROLIDE (LONG ACTING)
ELIGARD®
LUPRON DEPOT®
LUPRON DEPOT-PED®
LIDODERM
LIDODERM®
MYOBLOC
MYOBLOC®
NEULASTA
NEULASTA®
NEUPOGEN
NEUPOGEN®
PEGYLATED INTERFERONS
PEGASYS®
PEGINTRON REDIPEN®
PEGINTRON®
PENLAC
CICLOPIROX
PENLAC®
PROVIGIL
PROVIGIL®
RAPTIVA
RAPTIVA®
REBIF
REBIF®
REGRANEX
REGRANEX®
REMICADE
REMICADE®
REVATIO
REVATIO®
RITUXAN
RITUXAN®
SOMAVERT
SOMAVERT®
SPORANOX
ITRACONAZOLE
SPORANOX®
STRATTERA
STRATTERA®
SYMLIN
SYMLIN®
SYMLINPEN 120®
SYMLINPEN 60®
SYNAGIS
SYNAGIS®
TAZORAC
TAZORAC®
TOPAMAX/ZONEGRAN
TOPAMAX®
ZONEGRAN®
ZONISAMIDE
TOPICAL TRETINOIN PRODUCTS
ATRALIN®
AVITA®
RETIN-A MICRO®
RETIN-A®
TRETINOIN
ZIANA®
VFEND
VFEND®
XOLAIR
XOLAIR®
ZYVOX
ZYVOX®
Index
ACTIQ/FENTORA
Affected Drugs
ACTIQ®
FENTANYL CITRATE
FENTORA®
Covered Uses
All FDA approved indications not otherwise excluded from Part D.
Exclusion Criteria
Breakthrough Chronic (Non-Cancer) Pain. Acute and/or postoperative pain including surgery/post-surgery, trauma/post-trauma, acute medical illness (acute abdominal pain, pelvic pain, muscle spasm). Pre-anesthesia (preoperative anxiolysis and sedation and/or supplement to anesthesia. Coverage is not recommended for circumstances not listed in the Covered Uses.
Required Medical Information
N/A
Age Restrictions
N/A
Prescriber Restrictions
N/A
Coverage Duration
Authorization will be for 12 months, unless otherwise specified.
Other Criteria
Breakthrough pain in Pts with cancer if Pt is unable to swallow, has dysphagia, esophagitis, mucositis, or uncontrollable nausea/vomiting OR Pt is unable to take 2 other short-acting narcotics (eg, oxycodone, morphine sulfate, hydromorphone, etc) secondary to allergy or severe adverse events AND Pt is on or will be on a long-acting narcotic (eg, Duragesic), or the Pt is on intravenous, subcutaneous, or spinal (intrathecal, epidural) narcotics (eg, morphine sulfate, hydromorphone, fentanyl citrate).
ALPHA-1 PROTEINASE INHIBITORS
Affected Drugs
ARALAST®
PROLASTIN®
ZEMAIRA®
Covered Uses
All FDA approved indications not otherwise excluded from Part D. Other phenotypes with an alpha1-antitrypsin serum concentration less than 11 microM (11 micromol/L) or 80 mg/dL (eg, PiSZ phenotype). AAT deficiency-associated panniculitis.
Exclusion Criteria
PiMZ or PiMS phenotype of alpha1-antitrypsin deficiency, unless alpha1-antitrypsin serum concentrations are less than 11 microM (11 micromol/L) or 80 mg/dL. Cystic fibrosis. COPD without alpha1-antitrypsin deficiency. Alpha1-antitrypsin deficiency without lung disease, even if deficiency-induced hepatic disease is present. Bronchiectasis (without alpha1-antitrypsin deficiency). Coverage not recommended for anything not listed under Covered Uses.
Required Medical Information
For AAT deficiency and emphysema of other phenotypes that are not FDA-approved (eg, PiSZ, PiMZ or PiMS phenotype), an alpha1-antitrypsin serum concentration of less than 11 microM (11 micromol/L) or 80 mg/dL is required.
Age Restrictions
N/A
Prescriber Restrictions
N/A
Coverage Duration
Authorization will be for 12 months, unless otherwise specified.
Other Criteria
For AAT deficiency and emphysema of other phenotypes that are not FDA-approved (eg, PiSZ, PiMZ or PiMS phenotype), an alpha1-antitrypsin serum concentration of less than 11 microM (11 micromol/L) or 80 mg/dL is required.
AMEVIVE
Affected Drugs
AMEVIVE®
Covered Uses
All FDA approved indications not otherwise excluded from Part D.
Exclusion Criteria
N/A
Required Medical Information
.
Age Restrictions
Greater than or equal to 16 years of age.
Prescriber Restrictions
Plaque psoriasis.Prescribed by a dermatologist.
Coverage Duration
Plaque psoriasis or PsA,12 wks of tx. May get 2nd 12 wks if other conditions met
Other Criteria
Plaque psoriasis.Patient has chronic (greater than or equal to 1 year) plaque psoriasis AND Patient has tried a systemic therapy (e.g.,MTX,azathioprine,cyclosporine,Soriatane,Prograf,Raptiva,Enbrel,Remicade, Cellcept,6-thioguanine, sulfasalazine,hydroxyurea,propylthiouracil, OR oral methoxsalen plus UVA light [PUVA]) for psoriasis. Rarely, a patient may have contraindications to nearly all of these other therapies and exceptions can be made on a case-by-case basis.
ANABOLIC STEROIDS
Affected Drugs
ANADROL-50®
OXANDRIN®
OXANDROLONE
Covered Uses
All FDA approved indications not otherwise excluded from Part D. Plus Oxandrin for inclusion body myositis (IBM) sporadic form. Oxandrin for ALS for maintenance/improvement in muscle strength and/or respiratory capacity. Oxandrin for quadriplegic/tetraplegic patients for maintenance/improvement in respiratory muslce strength, pulmonary function, and/or dyspnea. Oxandrin for Duchenne muscular dystrophy. Oxandrin for constitutional delay of growth or growth and puberty in prepubertal boys with psychosocial difficulties or psychological distress due to their condition. Oxandrin for girls (8 y/o and older) w/Turner's Syndrome or Ullrich-Turner Syndrome and concomitantly receiving growth hormone therapy. Oxandrin for management of protein catabolism w/burns or burn injury if patients have tried a beta-blocker or have a contraindication to beta-blocker use. Oxandrin for AIDS wasting and cachexia due to a chronic disease. Oxandrin for cachexia due to cancer. Anadrol-50 for prevention/prophylaxis of hereditary angioedema after the patient has tried danazol. Anadrol-50 for AIDS wasting and cachexia due to a chronic disease.
Exclusion Criteria
Coverage of Oxandrin AND Anadrol-50 is not recommended in the following circumstances: Management of weight loss. HIV-associated lipodystrophy. Chronkhite-Canada Syndrome. Heart failure in patients with idiopathic dilated cardiomyopathy (IDC), mitral regurgitation, or aortic regurgitation. Athletic performance (ability) enhancement. Coverage is not recommended for circumstances not listed in the Covered Uses.
Required Medical Information
N/A
Age Restrictions
N/A
Prescriber Restrictions
N/A
Coverage Duration
Authorization will be for 12 months, unless otherwise specified.
Other Criteria
Oxandrin for the management of protein catabolism associated with burns/burn injury if patient has tried a beta-blocker (e.g., propranolol, metoprolol) or patient has a contraindication to beta-blocker use. Anadrol-50 for prevention/prophylaxis of hereditary angioedema after the patient has tried danazol.
ARANESP
Affected Drugs
ARANESP®
Covered Uses
All FDA approved indications not otherwise excluded from Part D worded as anemia associated with CRF, including patients on dialysis and not on dialysis, if hemoglobin (Hb) is less than or equal to 11.0 g/dL for therapy initiation. If the patient has previously been receiving darbepoetin or epoetin alfa, approve only if Hb is less than or equal to 12.0 g/dL. Deny darbepoetin if hemoglobin exceeds 12.0 g/dL if previously receiving the product for this indication and in any situation (continuation or initiation). Anemia in cancer due to chemotherapy approve for 4 months if the patient has a Hb less than or equal to 10.0 g/dL or Hb is greater than 10.0 g/dL but less then or equal to 12.0 g/dL and the physician anticipates a Hb decrease or the patient has comorbidities that require higher Hb levels. Also, deny darbepoetin if Hb is greater than 12.0 g/dL if previously receiving the product for this indication and in any situation (continuation or initiation). Anemia due to myelodysplastic syndrome (MDS) but do not approve if Hb is greater than 12.0 g/dL if previously receiving the product for this indication and in any situation (continuation or initiation).
Exclusion Criteria
Anemia associated with cancer. Anemia associated with AML, CML or other myeloid cancers. Anemia associated with radiotherapy in cancer. To enhance athletic performance. Treatment of anemia in inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease). Anemia in patients due to acute blood loss. Anemia in heart failure. Anemia associated with the use of ribavirin therapy for hepatitis C (in combination with interferon or pegylated interferon alfa 2a/2b products). Coverage not recommended for anything not listed under Covered Uses.
Required Medical Information
Hb value of less than or equal to 11.0 g/dL required for initiation of therapy in chronic renal failure (CRF). Also, in CRF Hb has to be less than or equal to 12.0 g/dL if previously receiving epoetin alfa or darbepoetin. CRF indication should be denied if Hb exceeds 12.0 g/dL for this condition and in any situation (continuation or initiation). For anemia in cancer patients due to chemotherapy a Hb of less than or equal to 10.0 g/dL is required or if Hb is greater than 10.0 g/dL but less than or equal to 12.0 g/dL the physician must anticipate a Hb decrease or the patient has comorbidities that require higher Hb levels. Deny darbepoetin in any situation that Hb is greater than 12.0 g/dL in cancer due to chemotherapy. For MDS, deny darbepoetin if hemoglobin is greater than 12.0 g/dL.
Age Restrictions
N/A
Prescriber Restrictions
N/A
Coverage Duration
4 mos anemia in cancer pts d/t chemotherapy. Other indications x 12 mos, unless other specified
Other Criteria
Anemia due to myelodysplastic syndrome (MDS) but treatment with darbepoetin is not allowed if Hb greater than 12.0 g/dL at anytime point.
ARCALYST
Affected Drugs
ARCALYST®
Covered Uses
All FDA approved indications not otherwise excluded from Part D.
Exclusion Criteria
N/A
Required Medical Information
N/A
Age Restrictions
N/A
Prescriber Restrictions
N/A
Coverage Duration
12 months
Other Criteria
N/A
AVONEX
Affected Drugs
AVONEX ADMINISTRATION PACK®
AVONEX®
Covered Uses
All FDA approved indications not otherwise excluded from Part D worded as patients with a diagnosis of MS or have experienced an attack and who are at risk of MS and prescribed by, or after consultation with, a neurologist or an MS-specialist.
Exclusion Criteria
Concurrent use of Rebif, Betaseron, Copaxone or Tysarbi. Coverage not recommended for anything not listed under Covered Uses
Required Medical Information
N/A
Age Restrictions
N/A
Prescriber Restrictions
Prescribed by or after consultation with a neurologist or an MS specialist.
Coverage Duration
Authorization will be for 12 months.
Other Criteria
N/A
B vs D - Part B versus Part D Coverage PA
Affected Drugs
ANZEMET®
AZASAN®
AZATHIOPRINE
CARIMUNE NF NANOFILTERED®
CELLCEPT®
CESAMET®
CYCLOPHOSPHAMIDE
CYCLOSPORINE
CYTOXAN®
DRONABINOL®
EMEND®
ENGERIX-B®
FLEBOGAMMA®
GAMASTAN S-D®
GAMMAGARD LIQUID®
GAMUNEX®
GENGRAF
GRANISETRON HCL
GRANISOL®
IMURAN®
IVEEGAM EN®
KYTRIL®
MARINOL®
METHOTREXATE
MYFORTIC®
NEORAL®
OCTAGAM®
ONDANSETRON HCL
ONDANSETRON ODT
PANGLOBULIN NF®
PANGLOBULIN®
PHENERGAN®
POLYGAM S-D®
PROGRAF®
PROMETHAZINE HCL
RAPAMUNE®
RECOMBIVAX HB®
SANDIMMUNE®
TREXALL®
ZOFRAN ODT®
ZOFRAN®
Covered Uses
This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination.
BETASERON
Affected Drugs
BETASERON®
Covered Uses
All FDA approved indications not otherwise excluded from Part D worded as patients with a diagnosis of MS or have experienced an attack and who are at risk of MS and prescribed by, or after consultation with, a neurologist or an MS-specialist.
Exclusion Criteria
Concurrent use of Avonex, Rebif, Copaxone or Tysarbi. Coverage not recommended for anything not listed under Covered Uses.
Required Medical Information
N/A
Age Restrictions
N/A
Prescriber Restrictions
Prescribed by or after consultation with a neurologist or an MS specialist.
Coverage Duration
Authorization will be for 12 months, unless otherwise specified.
Other Criteria
N/A
BOTOX
Affected Drugs
BOTOX®
Covered Uses
All FDA approved indications not otherwise excluded from Part D. Plus Achalasia. Anal Fissure. BPH after a trial with at least 2 other therapies. Chronic facial pain/pain associated with TMJ dysfunction. Chronic low back pain if after trial of at least 2 other pharmacologic therapies AND if being used as part of a multimodal therapeutic pain management program. Plantar fasciitis. Tinnitus after a trial with at least 2 other pharmacologic therapies AND tinnitus retraining therapy AND prescribed by an ENT. Headache (migraine, chronic tension HA, whiplash, chronic daily HA) after trial with at least 2 other pharmacologic therapies AND prescribed by or in consultation with a neurologist or HA specialist. Palmar/plantar and facial hyperhidrosis after trial with at least 1 topical agent. Myofascial pain. Salivary hypersecretion. Spasticity (eg, due to cerebral palsy, stroke, brain injury, spinal cord injury, MS, hemifacial spasm). Essential tremor after a trial with at least 1 other pharmacological therapy. Dystonia other than cervical (eg, focal dystonias, tardive dystonia, anismus). Bladder/voiding/urethral dysfunction after trial with at least 1 other pharmacologic therapy. Gastroparesis after a trial with at least 1 promotility drug. Vaginismus after a trial with at least 2 other treatment options. Dysphagia. Interstitial cystitis. Frey's syndrome. Ophthalmic disorders (eg, esotropia, exotropia, nystagmus, facial nerve paresis). Speech/voice disorders (eg, dysphonias). Tourette's syndrome after a trial with at least 1 more commonly used pharmacologic therapy. Crocodile tears syndrome. Fibromyalgia after a trial of at least 2 commonly used pharmacologic therapies.
Exclusion Criteria
Cosmetic uses (eg, facial rhytides, frown lines, glabellar wrinkling, horizontal neck rhytides, mid and lower face and neck rejuvenation, platsymal bands, rejuvenation of the peri-orbital region. Allergic rhinitis. Gait freezing in Parkinsons disease. Coverage not recommended for anything not listed under Covered Uses.
Required Medical Information
N/A
Age Restrictions
N/A
Prescriber Restrictions
Tinnitus if prescribed by ENT. Headache if prescribed by, or after consultation with, a neurologist or HA specialist.
Coverage Duration
Authorization will be for 12 months, unless otherwise specified.
Other Criteria
Primary axillary hyperhydrosis after trial with at least 1 topical agent (eg, aluminum chloride). BPH after trial with at least 2 other therapies (eg, alpha1-blocker, 5 alpha-reductase inhibitor, TURP, transurethral microwave heat treatment, TUNA, interstitial laser therapy, stents, various forms of surgery). Chronic low back pain after trial with at least 2 other pharmacologic therapies (eg, NSAID, antispasmodics, muscle relaxants, opioids, antidepressants) and if being used as part of a multimodal therapeutic pain management program. Tinnitus after a trial with at least 2 other pharmacologic therapies (eg, lidocaine, antihistamines, antidepressants, anxiolytics, diuretics, anticonvulsants, antispastics) and tinnitus retraining therapy and prescribed by an ENT (eg, otolaryngologist). Headache (eg, migraine, chronic tension headache, whiplash, chronic daily headache) after a trial with at least 2 other pharmacologic therapies and prescribed by or after consultation with a neurologist/headache specialist. Palmar/plantar and facial hyperhidrosis after a trial with at least 1 topical agent (eg, aluminum chloride). Essential tremor after a trial with at least 1 other pharmacologic therapy (eg, primidone, propranolol, benzodiazepines, gabapentin, topiramate). Bladder/Voiding/Urethral dysfunction after a trial with at least 1 other pharmacologic therapy. Gastroparesis after a trial with at least 1 promotility drug (eg, metoclopramide, tegasterod, erythromycin). Vaginismus after a trial with at least 2 other treatment options (eg, behavior therapy, psychotherapy, biofeedback, dilatation techniques, deep muscle relaxation exercises, anesthetic creams, vaginal lubricants, propranolol, alprazolam). Interstitial cystitis after a trial with at least 1 other pharmacologic therapy (eg, pentosan polysulfate, heparin, antihistamines, TCAs, intravesical dimethyl sulfoxide, bacilli Calmette-GuTrin). TouretteÆs syndrome if after a trial with at least 1 more commonly used pharmacologic therapy (eg, neuroleptics, clonidine, SSRIs, psychostimulants). Fibromyalgia if after a trial of at least 2 or more commonly used pharmacologic therapies (eg, TCAs, SSRIs, SNRIs, dopamine agonists, and sedative hypnotics, or lidocaine injection into ôtrigger pointsö).
BYETTA
Affected Drugs
BYETTA®
Covered Uses
All FDA approved indications not otherwise excluded from Part D.
Exclusion Criteria
Weight loss treatment. Type 1 diabetes. Coverage not recommended for anything not listed under Covered Uses
Required Medical Information
N/A
Age Restrictions
N/A
Prescriber Restrictions
N/A
Coverage Duration
Authorization will be for 12 months, unless otherwise specified.
Other Criteria
Patient has inadequate glycemic control demonstrated on two-drug therapy (eg, metformin, sulfonylurea, thiazolidiedione).
CEREZYME
Affected Drugs
CEREZYME®
Covered Uses
All FDA approved indications not otherwise excluded from Part D. Type 1 Gaucher disease if being prescribed by, or after consultation with, a physician that specializes in the treatment of inherited metabolic disorders or the patient was referred to a center that specializes in the treatment of Gaucher disease. Type 2 or 3 Gaucher disease if the agent is being prescribed by, or after consultation with, a physician that specializes in the treatment of inherited metabolic disorders or the patient was referred to a center that specializes in the treatment of Gaucher disease.
Exclusion Criteria
Tay-Sachs disease. Coverage not recommended for anything not listed under Covered Uses
Required Medical Information
N/A
Age Restrictions
N/A
Prescriber Restrictions
Type 1, 2, or 3 Gaucher disease if prescribed by or after consultation with, a physician that specializes in the treatment of inherited metabolic disorders.
Coverage Duration
Authorization will be for 12 months, unless otherwise specified.
Other Criteria
N/A
CIMZIA
Affected Drugs
CIMZIA®
Covered Uses
All FDA approved indications not otherwise excluded from Part D.
Exclusion Criteria
Certolizumab pegol should not be given in comvination with anakinra. Rheumatoid arthritis (RA). Plaque psoriasis, Children with Crohn's disease. Coverage not recommended for anything not listed under Covered Uses.
Required Medical Information
N/A
Age Restrictions
Crohns disease in adults only.
Prescriber Restrictions
N/A
Coverage Duration
6 months
Other Criteria
Approve if patient has failed treatment with one or more conventional drugs (corticosteroids, Six MP, purinethol, azathioprine, or methotrexate) AND does not have a history of cancer as documented by a negative PPD test prior to initial treatment AND does not have a history of an autoimmune disease other than Crohns Disease.